Sr Quality Scientist

Sr Quality Scientist

Cepheid

Solna, Sweden

The Sr QA Scientist’s primary responsibility is quality assuring the Design Control process and representing Quality Assurance in assay development project core teams. Core team representation includes ensuring that the project follows established procedures, that deliverables are generated and have the proper content, and that risk management activities are performed and ensuring that risk management is integrated into the entire development process.

The role also includes assuring that post launch product design changes and stability studies are performed in accordance with established and compliant procedures, including assessment of changes to product claims.

The qualified candidate will be able to demonstrate leadership capability and skills necessary to drive continuous improvements and provide consultation and support to the organization to achieve compliant and effective processes.

You will responsible for

  • Represent Quality Assurance in project core teams with focus on Design Control;
  • Review and approve product and project documentation for compliance towards Cepheid’s Quality Management System and relevant regulatory requirements;
  • Facilitate and/or assure performing Risk Management activities throughout the entire Product Life Cycle;
  • Build working relationships with cross functional teams including R&D, Product Transfer, Program Management, Marketing, Regulatory Affairs, Clinical Affairs, Global Product Support and others to ensure efficient collaboration and reduce product time to market;
  • Participate in and ensuring that Design Reviews are continuously held and documented according to established procedures;
  • Work closely with R&D, Marketing, Regulatory Affairs and others to ensure product requirements and design output meet intended use and user needs;
  • Work closely with Quality Systems and Regulatory Affairs to ensure that established procedures in Cepheid’s Quality Management System are compliant with Food & Drug Administration (FDA) and European Union In-vitro Diagnostic Device Directives (IVDD), the coming In-vitro Diagnostic Regulation (IVDR) as well as all other applicable global regulatory requirements;
  • Support internal and external audits as Subject Matter Expert for Design Controls for assay projects.

What skills & experience you'll bring to us

  • University’s degree within Molecular Biology, Applied Sciences, Biotechnology & Biomedical Engineering;
  • Minimum 5 years of relevant experience in Quality Assurance role working with development of IVD tests, or similar experience from related areas;
  • Experience from leading risk management activities in medical device/diagnostic industry;
  • Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDD, ISO 13485 and ISO 14971;
  • Demonstrates knowledge in Molecular Biology and/or Virology or similar with understanding of relevant aspects for PCR based molecular tests;
  • Strong understanding of quality systems methodology and applications;
  • Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products;
  • Have strong interpersonal, writing and communication skills; fluent English in written and spoken; Swedish is an advantag;
  • Wants to work in a fast-paced environment with and manage continuous changes and improvements;
  • Is dedicated to product quality and customer satisfaction;
  • Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Sweden     Quality Assurance     Cepheid    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies